Regulatory Affair Strategy, Guidance and Support

Regulatory is the core of our business, therefore we have an experienced team who can help you with any of the topics below. We pride ourselves in helping clients, not only with strategy, but also implementation, which is key to successful commercialization.

Regulatory Strategy & Management of Drug Development

  • Provide regulatory advice in the early phases of development projects
  • Define the product concept
  • Interpret regulations and guidelines
  • Develop strategies for technical aspects of drug development (quality, preclinical and clinical)
  • Design and manage drug development programs
  • Determine market access requirements and develop a strategy in the early phases
  • Identify and manage external resources/experts

Regulatory Strategy

  • Establish frequent contact with regulatory authorities to facilitate compliance
  • Evaluate technical data (chemistry/manufacturing, preclinical, clinical), to help determine the appropriate regulatory procedure and legal status for products
  • Pro-actively consult with the regulatory authorities for scientific advice
  • Arrange and manage scientific advice meetings with regulatory authorities
  • Propose optimal filing and submission strategy

Regulatory Management & Implementation

  • Clinical trials applications
  • Dossier Preparation (CTD, eCTD)
  • Translation services
  • Submission process
  • Liaisons with Health Authorities
  • Post approval maintenance
  • Variations, Renewals, Pharmacovigilance, PSURs
  • Technical Expert Services

Rx to OTC Switching

  • Development of strategy to ensure national switches are planned and implemented to an international standard
  • Preparation of dossiers with full justification
  • Evaluation of the impact of reclassification on product reimbursement and pricing
  • Planning and implementation of parallel switches in several countries
  • Borderline Products

    An increasing number of products have to be characterized as borderline products – an ambiguity either due to an overlap between existing regulations or because the product is innovative and does not fall into any prospective regulation.

    Our services include:

    • Demarcation and identification of appropriate regulatory path with applicable legislation
    • Development of optimized regulatory strategies, aiming to achieve ideal marketability
    • Intermediation and close interaction with Competent authorities, Notified Bodies and other regulatory bodies in order to safeguard chosen strategies

    Our fields of expertise are

    • Medicinal products
    • Medical devices
    • Cosmetics
    • Food / food supplements / dietary foods / food for special medical purposes and the relevant borderline areas in between

Clients & Testimonials